Visitor Monitoring Drug History: UROXATRAL
 
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Label and Approval History

Drug Name: UROXATRAL
FDA Application No: (NDA) 021287
Active Ingredient(s): ALFUZOSIN HYDROCHLORIDE
Company: SANOFI AVENTIS US
 
Label History
 
View the label approved on March 31, 2007 for UROXATRAL, (NDA) 021287


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
3/29/2007 008Labeling Revision Letter
Label 
11/16/2006 007Labeling Revision Letter
Label 
3/17/2006 005Labeling Revision Letter
Label 
7/15/2003 001Labeling Revision Letter
Review 
6/12/2003 000Approval Letter
Label
Review
Consumer Information Sheet 
 
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